510(k) K021972 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY
| Applicant | Qualigen, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Aug 21, 2002 |
| Received | Jun 17, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021972
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 19, 2013 | Qualigen Inc FastPack Testosterone Immunoassay
Chemilunescence assay for the determination of Testosterone
The FastPack Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative dete Terminated |
CDZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.